Hi All,
Is it possible to obtain a medical device licence for the BF applied part only (non electrical) of a class II medical device system that is electrically controlled if the system as a whole has not been tested to Canadian electrical standards. The applied part will not function as intended without the electrical part of the system.
Jo
Is it possible to obtain a medical device licence for the BF applied part only (non electrical) of a class II medical device system that is electrically controlled if the system as a whole has not been tested to Canadian electrical standards. The applied part will not function as intended without the electrical part of the system.
Jo